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FDA 510(k)

AIO HD OTOSCOPE

K-Number: K123821 · 2013-05-17

ApplicantBlue Focus
Decision Date2013-05-17
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AIO HD OTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Blue Focus. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K123821. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIO HD OTOSCOPE?

AIO HD OTOSCOPE is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Blue Focus. The 510(k) number is K123821.

When did AIO HD OTOSCOPE receive FDA 510(k) clearance?

AIO HD OTOSCOPE received FDA 510(k) clearance on 2013-05-17, under 510(k) number K123821.

Who is the listed applicant for AIO HD OTOSCOPE?

The FDA 510(k) record lists Blue Focus as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIO HD OTOSCOPE?

The FDA product code for AIO HD OTOSCOPE is ERA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ERA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.K950913PERFECT, ENT SET, PRAKTIKANT, DE LUXERudolf Riester GmbH & Co. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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